Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.

Not Applicable

• Conditions: Success of Inferior Alveolar Nerve Block
• Interventions: Drug: Mepivacaine-Levonordefrin Hydrochloride; Drug: Magnesium sulfate

• Registration Number: NCT04561921
• Lead Sponsor: Cairo University

Brief Summary

the study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-20
• Study First Posted: 2020-09-24
• Last Update Submitted: 2020-09-26
• Last Update Posted: 2020-09-29
• Study Start: 2020-10-22
• Primary Completion: 2021-10-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Age between 18-55 years old.

2. Systemically healthy patient (ASA I or II).

3. Mandibular molar teeth with:

   • Preoperative sharp pain.
   • No widening in the periodontal ligament (PDL).
   • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray)1.
   • Fully formed roots.

4. Positive patient's acceptance for participation in the study.

Exclusion Criteria

1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment.
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Drug abusers and subjects who were on antidepressant medication.
5. Re-treatment cases.
6. Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mepivacaine HCl	Mepivacaine-Levonordefrin Hydrochloride	Injection of 1.8 mL of a local anaesthetic solution containing 1.8% mepivacaine HCL with .06mg Levonordefrin HCL during inferior alveolar nerve block
megnesium sulphate	Magnesium sulfate	Injection of 1.8 mL of an anaesthetic solution containing 1% magnesium sulphate , and 1.8% mepivacaine HCL with .06mg Levonordefrin HCl during inferior alveolar nerve block.

Primary Outcome Measures

Name	Time	Method
success of inferior alveolar nerve block measured using a numerical rating scale (NRS)	15 minutes after injection	Intensity of pain 15 minutes after injection during access cavity and initial file placement is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )